GSK’s successful respiratory vaccine has been approved for a younger age group, providing a boost for the pharmaceutical company over its rival Pfizer.
The US Food and Drug Administration (FDA) has given the green light for Arexvy to be prescribed to patients between 50 and 59 years old.
The vaccine protects against respiratory syncytial virus (RSV), which causes cold-like symptoms but can be dangerous for the elderly, newborns and vulnerable people.
It has the potential to prevent thousands of hospital admissions each year.
Arexvy was the world’s first RSV vaccine when it launched in the US last year, but it faces competition from alternatives made by Pfizer and Moderna.
Approved: The US Food and Drug Administration has given the green light for GSK’s Arexvy respiratory vaccine to be prescribed to patients between 50 and 59 years old
The success of the shot has been seen as a sign that GSK chief executive Emma Walmsley’s turnaround strategy has begun to bear fruit.
In 2022, Walmsley revealed plans to refocus the pharmaceutical giant on vaccines and infectious diseases, which included the sale of its consumer healthcare division, Haleon.
The pivot came after GSK fell behind rival Astrazeneca and US competitor Pfizer in creating a Covid vaccine during the pandemic.
Yesterday’s announcement makes the £1.2bn vaccine the first FDA-backed RSV vaccine for under-60s.
However, GSK will have to wait to see if the U.S. Centers for Disease Control and Prevention approves expanded use when they meet later this month.
Arexvy generated around £1.2bn in sales last year, surpassing the £699m in revenue generated by Pfizer’s rival drug.
The vaccine has been approved in Europe, Canada and Japan for people over 60 years of age.
However, it is not available in the UK despite receiving initial approval in July 2023.
GSK has avoided a showdown in Illinois courts over its aging heartburn drug Zantac after the plaintiff withdrew its lawsuit before the trial began yesterday.
Zantac has come under a wave of scrutiny with around 74,000 cases filed alleging the drug causes cancer.
GSK added that the “scientific consensus” is that there is no “consistent or reliable evidence” that Zantac increases the risk of cancer.